Production and Industrial - Quality Control

Job Description: POSITION SUMMARY
Using standard operating procedures (SOP) and good manufacturing practices (GMP) the QC Engineer/Scientist I will perform testing of raw materials as part of the Incoming Material process before they can be used to build filled components and finished goods kits. The QC Engineer/Scientist I will be responsible for all aspects of laboratory testing such as sample receipt data generation data analysis and summarization instrument operation and other QC lab supporting activities.

Responsibilities:
Conducts analytical and functional testing of raw materials according to approved SOPs
Perform testing using typical laboratory instrumentation including chemistry clinical analyzers and document test results accurately using Excel spreadsheets and workbooks.
Documents test results complete batch records document problems and other relevant information under cGMPs.
Perform simple revisions and updates to QCs SOPs and/or worksheets as necessary and initiate procedure change orders.
Summarize test data maintain lot histories and evaluate data for trends and discrepancies.
Performs other responsibilities to support the needs of the department as assigned by Supervisor.
Participate in PPI Lean and 5S programs as required.

Minimum Requirements/Qualifications:
Minimum BS/BA in Chemistry Biochemistry or Bioscience with 02 yrs Quality Assurance/Quality Control experience preferably in the medical diagnostics industry.
Demonstrated ability and/or additional experience may be considered in lieu of a BS/BA degree.
Strong laboratory skills including pipetting safety and hazardous chemical handling.
Understanding of cGMP and how it applies to the work environment is preferred.
High level of reading comprehension skills.
Ability to follow written and verbal directions with a high level of accuracy.
Must be able to write clear understandable documentation.
High level of verbal communication skills.
Manual dexterity must be able to lift/move up to 20 pounds.
Intermediate word processing and spreadsheet software skills.
Ability to manage multiple tasks simultaneously.
Ability to work independently.
Ability to perform simple data analysis and to summarize results.
Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.

Shift: 8am5pm MF
Work Location: 46500 Kato Rd. Fremont CA
Possibility for OT: minimal
Contract Length: 12 months
Possibility for Temp to Perm: depends on need.
What is the reason this role is open (new replacement covering a leave of absence etc.) new position increased work load
Day to day: mostly lab based expect them to testing material 6080 % of the time rest doing paperwork. Raw material testing.
What is the dress code for this role Business casual lab attire closed toed shows long pants.
Comfortable working with biological materials testing can be done on blood and urine.
Additional Sills: Skills: No items to display.